Orthopedic shoulder device

ABSTRACT

Methods of manufacturing an orthopedic shoulder device is provided. The method includes providing a cradle device configured to receive and support a portion of an arm of a user. The method includes assembling an abduction positioning device by coupling the cradle device to an apex of a flexible arch utilizing a rotation coupling member such that adjusting an amount of curvature of the flexible arch adjusts an angle of abduction of the arm of the user relative to a torso of the user. The method includes providing at least one strap for coupling between at least two locations on the flexible arch such that the amount of curvature of the flexible arch is adjusted by adjusting an amount of the at least one strap coupled between the at least two locations on the flexible arch. Methods of utilizing such an orthopedic shoulder device are also provided.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.17/588,840, filed on Jan. 31, 2022 and issuing as U.S. Pat. No.11,771,582 on Oct. 3, 2023, which is a continuation of U.S. applicationSer. No. 16/578,817, filed on Sep. 23, 2019, now U.S. Pat. No.11,234,855, which is a continuation application of U.S. application Ser.No. 15/084,368, filed on Mar. 29, 2016, now U.S. Pat. No. 10,420,670,which is a continuation application of International Application No.PCT/US2014/058455, filed Sep. 30, 2014, which claims priority to U.S.Provisional Application No. 61/885,394, filed on Oct. 1, 2013, U.S.Provisional Application No. 62/045,469, filed on Sep. 3, 2014 and U.S.Provisional Application No. 62/056,814, filed on Sep. 29, 2014, theentire contents of which is hereby incorporated by reference.

TECHNICAL FIELD

The present disclosure relates generally to orthoses, and moreparticularly, to a shoulder orthosis for supporting and stabilizing theshoulder following surgery or injury.

BACKGROUND

The shoulder is a relatively complex joint of the body which is capableof rotation within multiple planes when the arm is displaced relative tothe torso. Treatment of shoulder injury frequently requires determininga desired optimal treatment position of the shoulder and associated arm,placement of the shoulder and arm in the desired treatment position.Such a recuperative treatment is particularly applicable to soft tissueinjuries involving damage to one or more connective shoulder ligamentsand furthermore is often the treatment of choice following any number ofsurgical procedures, such as surgery for recurrent posteriorsubluxation, rotator cuff surgery, humeral head or shaft fracturecorrection, and similar.

Support devices for the shoulder, such as orthopedic braces, rigidcasts, and slings are commonly used to perform the placement andimmobilization. However, there remains a need for shoulder orthoseswhich provide greater stability, immobilization, and comfort.

BRIEF DESCRIPTION OF THE DRAWINGS

While the appended claims set forth the features of the presenttechniques with particularity, these techniques, together with theirobjects and advantages, may be best understood from the followingdetailed description taken in conjunction with the accompanying drawingsof which:

FIG. 1A illustrates a front elevation view of a shoulder brace, orrecovery brace, according to an embodiment of the disclosure;

FIG. 1B illustrates a rear elevation view of the shoulder brace of FIG.1A, in a fully assembled state as worn by a user;

FIG. 2A illustrates a plan view of a shoulder strap of the shoulderbrace of FIGS. 1A and 1B;

FIG. 2B illustrates a side elevation view of a body member and a waiststrap of the shoulder brace of FIGS. 1A and 1B;

FIG. 3 illustrates a perspective view of a spacer of the shoulder braceof FIGS. 1A and 1B;

FIG. 4 illustrates a perspective view of the spacer from a viewpointgenerally opposite to that of FIG. 3 ;

FIG. 5A illustrates a rear elevation view of an arm member of theshoulder brace of FIGS. 1A and 1B;

FIG. 5B illustrates a front elevation view of the arm member of theshoulder brace of FIGS. 1A and 1B;

FIG. 6 illustrates a perspective view of a shoulder brace according toan embodiment of the disclosure;

FIG. 7 illustrates a shoulder brace according to an embodiment of thedisclosure;

FIG. 8 illustrates a waist belt having a flat orientation prior tofitting the belt to a patient;

FIG. 9 illustrates a rear isometric view of a waist belt center panel;

FIG. 10 illustrates an isometric view of a wedge assembly;

FIG. 11 illustrates a cross-sectional view of an external/internalrotation coupling member;

FIG. 12A illustrates an outer isometric view of an arm shell assembly;

FIG. 12B illustrates an inner isometric view of an arm shell assembly;

FIG. 13 illustrates an arm shell having a coupling feature;

FIG. 14 illustrates an arm shell having two symmetric components;

FIG. 15 illustrates a three-dimensional view of an arm shell accordingto an embodiment of the disclosure;

FIG. 16 illustrates a three-dimensional view of a wedge assemblyattached to a waist belt according to an embodiment of the disclosure;

FIG. 17 illustrates a shoulder brace according to an embodiment of thedisclosure;

FIG. 18 illustrates an abduction arch connected to an external/internalrotation coupling member;

FIG. 19 illustrates a cross-sectional view of the external/internalrotation coupling member of FIG. 18 ;

FIG. 20 illustrates an inner strap configuration of a support device;

FIG. 21 illustrates an outer strap configuration of a support device;

FIG. 22 illustrates a plurality of y-shaped strap outer strap designs;

FIG. 23 illustrates an assembled support device; and

FIG. 24 illustrates an assembled shoulder brace according to anembodiment of the disclosure.

DETAILED DESCRIPTION

Turning to the drawings, wherein like reference numerals refer to likeelements, techniques of the present disclosure are illustrated as beingimplemented in a suitable environment. The following description isbased on embodiments of the claims and should not be taken as limitingthe claims with regard to alternative embodiments that are notexplicitly described herein.

The phrases “connected to,” “coupled to” and “in communication with”refer to any form of interaction between two or more entities, includingmechanical, electrical, magnetic, electromagnetic, fluid, and thermalinteraction. Two components may be functionally coupled to each othereven though they are not in direct contact with each other. The term“abutting” refers to items that are in direct physical contact with eachother, although the items may not necessarily be attached together. Thephrase “fluid communication” refers to two features that are connectedsuch that a fluid within one feature is able to pass into the otherfeature.

The word “exemplary” is used herein to mean “serving as an example,instance, or illustration.” Any embodiment described herein as“exemplary” is not necessarily to be construed as preferred oradvantageous over other embodiments. While the various aspects of theembodiments are presented in drawings, the drawings are not necessarilydrawn to scale unless specifically indicated.

The word “orthosis” or “orthotic” is used herein to mean a brace orother such device. Consequently, orthosis may be used interchangeablywith the term “brace” and may refer to specific types of braces whenindicated (e.g., a shoulder orthosis or shoulder brace).

The word “neutral” is used herein to mean at or about zero degrees froma centermost position or plane. Thus, when positioning the arm from auser's body, neutral may refer to a plane parallel to a user's spine. Incontrast, “resting” is used herein to take into account some deviationfrom neutral. Thus, when positioning the arm from a user's body, restingmay refer to the position the arm naturally rests against the user'sbody.

Embodiments of this disclosure relate to a shoulder brace forimmobilization of the shoulder. Advantages of the shoulder brace includeits lightweight construct, easy application, including reduced number ofsteps to apply brace as well as quick connect fasteners, quick and easyadjustable abduction, and adjustable external/internal rotation.Additional features include the ability to employ a precise amount ofabduction and external/internal rotation as well as a breathable designwith a drop-out feature.

In some embodiments, a rigid shoulder brace, is provided whichimmobilizes the arm, and in turn the shoulder joint, in neutralabduction/adduction to 45°, external rotation of between about 0-50° andinternal rotation of between about 0-60°. The shoulder orthosis includesa cradle device (e.g., arm shell), an abduction positioning device(e.g., abduction wedge or adduction arch), and a support device (e.g.,waist straps or belt). Such orthosis provides a low-profile design whileminimizing the need for additional straps. Additionally, the cradledevice can include a drop out design to allow for flexion/extension ofthe forearm which facilitates daily living activities.

Current products on the market are bulky and employ a shoulder strapwhich can impinge on the nerves in the area of the clavicle causing neckpain and discomfort. By using a waist belt design to support the weightof the arm, shoulder devices or orthosis provided herein eliminate theneed for shoulder straps, thus eliminating the associated pain anddiscomfort. Additionally, the low-profile design of the waist belt andabduction positioning device reduce the bulk and weight seen in otherdesigns and allow for more breathability, thus reducing patientdiscomfort while wearing the orthosis.

In some embodiments, multiple pathologies can be addresses with oneorthosis, including, but not limited to: glenohumeral dislocation orsubluxation, capsular shifts, posterior shoulder stabilizations, Bankartrepairs, release severe anterior capsule contracture, soft tissuestrains or repairs, rotator cuff repairs, total shoulder replacement,superior labral repairs (SLAP), shoulder debridement, fractures(humerus, elbow, forearm), biceps tendon repair, elbow ligament/tendonrepair, anterior shoulder luxation and AC joint reconstruction.

Referring to FIG. 1A, a front elevation view illustrates a shoulderbrace 100 according to one embodiment of the disclosure, in a fullyassembled state as worn by a user 110. Shoulder brace 100 may bedesigned to facilitate the recovery of the user 110. The user 110 mayhave an arm 112 connected to the body of the user 110 with a shoulder114.

The arm 112 may include an upper arm 116, an elbow 118, a forearm 120, awrist 122, and a hand 124. The user may further have a torso 126.

The brace 100 may be designed to help the user 110 to recover from asurgical procedure such as described above, which may necessitate avariety of arm positions for recovery. Known recovery braces such asslings and other shoulder immobilizers, in many cases, lack theflexibility to be used to facilitate recovery from different types ofinjury or surgery. The user 110 would benefit from a device that allowsstable positioning of the shoulder at different angles to facilitaterecovery from a wide variety of shoulder procedures.

Brace 100 may have a modular design that facilitates the positioning ofthe arm 112 at multiple different orientations relative to the torso 126of the user 110. More particularly, the brace 100 may have a body member130, a spacer 132, an arm member 134, a waist strap 136, and a shoulderstrap 138. The body member 130 may rest against the torso 126 of theuser 110, and may be held in place by the waist strap 136. The waiststrap 136 may be formed of a flexible material, and may have anadjustable length, or may be adjustably secured to the body member 130via buckles, clasps, fasteners such as a hook and loop fastener, or thelike.

The arm member 134 may be attached to and spaced apart from the bodymember 130 via the spacer 132, which may have a wedge shape thatpositions the forearm 120 further from the torso 126 than the upper arm116, allowing for a relatively natural position of the arm 112. Theshoulder strap 138 may be used to support the body member 130 and/or thearm member 134 at the desired elevation, with the aid of the othershoulder of the user 110.

The arm member 134 may have an upper arm band 140 and a wrist band 142that grip the upper arm 116 and the wrist 122 of the user 110,respectively. The upper arm band 140 and the wrist band 142 may eachinclude a flexible strap or other element that is detachably secured tothe arm 112. Buckles, clasps, fasteners such as hook and loop fasteners,or other detachable elements may be used. Optionally, a forearm band(not shown) may be included, which may grip the forearm 120 of the user110. Such a forearm band, if included, may be located between the wristband 142 and the elbow 118 of the user 110.

Advantageously, the independent attachment of the brace 100 to the arm112 may enable the user 110 to carry out certain tasks that may not bepossible with known brace designs. For example, the wrist band 142 maybe detached from the wrist 122 to enable the user 110 to performfunctions that may require two hands, such as eating, washing, typing,driving or the like. Once the activity is complete, the wrist band 142may be re-attached to the wrist 122 to again provide support to thewrist 122.

Referring to FIG. 1B, a rear elevation view illustrates the brace 100 ofFIG. 1A, in a fully assembled state as worn by the user 110. As furthershown in FIG. 1B, the shoulder strap 138 may be secured to the bodymember 130 on the rear, and to the arm member 134 on the front. Inalternative embodiments, the front and back ends of the shoulder strap138 may be secured to any combination of the body member 130, the spacer132, the arm member 134, the waist strap 136, and/or any otheracceptable anchor point, including other straps or items of apparel wornby the user 110.

Referring to FIG. 2A, a plan view illustrates the shoulder strap 138 ofthe brace 100 of FIGS. 1A and 1B in greater detail. As shown, theshoulder strap 138 may have a forward end 150, a rearward end 152, andan intermediate portion 154. The forward end 150 may be detachablyconnected to the arm member 134 as shown in FIG. 1A. The forward end 150may have a forward fastener 156, which may be a buckle that engages acorresponding member permanently attached to the arm member 134.Similarly, the rearward end 152 may be detachably connected to the bodymember 130 as shown in FIG. 1B. The rearward end 152 may have a rearwardfastener 158, which may also be a buckle that engages a correspondingmember permanently attached to the body member 130.

In some embodiments, the forward fastener 156 and/or the rearwardfastener 158 may include other fastening elements besides buckles. Suchfastening elements include, but are not limited to clips, clasps, hookand loop systems, and the like.

If desired, the intermediate portion 154 may be wider than the forwardend 150 and/or the rearward end 152, as illustrated, in order todistribute the weight carried by the shoulder strap 138 over a broaderportion of the other shoulder of the user 110. Additionally, oralternatively, the intermediate portion 154 may include padding, moreand/or less abrasive materials, and/or other aspects that enhance thecomfort level of the user 110, who may be wearing the brace 100 for anextended period of time.

Referring to FIG. 2B, a side elevation view illustrates the body member130 and the waist strap 136 of the brace 100 in isolation from theremaining components of the brace 100. As shown, the waist strap 136 mayhave a first end 160 and a second end 162. The first end 160 may besecured to the body member 130 through the use of a first fastener 164,which may be adjustable to allow the recovery brace 100 to be used forpatients of different sizes, genders, ages, etc. The first fastener 164may optionally include a hook and loop fastener that can easily befastened at multiple different positions to effectively vary the lengthof the waist strap 136. The second end 162 may be attached to the bodymember 130 via a similar fastening arrangement, with a differentremovable fastening system, or via a permanent attachment whereby thelength of the waist strap 136 is adjusted only via the first fastener164.

The body member 130 may have a forward end 166, a rearward end 168, atop end 170, and a central portion 172. The body member 130 mayoptionally have a T-shape as shown, wherein the forward end 166, therearward end 168, and the top end 170 each define extensions from thecentral portion 172. The T-shape illustrated may provide for enhanceduser comfort via the forward end 166 and the rearward end 168, whileenhancing the support provided to the arm 112 via the top end 170.However, the T-shape shown in FIG. 2B is optional, and may be replacedwith a wide variety of shapes.

The body member 130 may be attached to the waist strap 136 as shown, andalso to the spacer 132 and the shoulder strap 138, as shown in FIGS. 1Aand 1B. Thus, the body member 130 may have a plurality of attachmentfeatures that facilitate such attachment.

For example, the body member 130 may have a forward attachment feature174 that facilitates attachment of the first fastener 164 of the waiststrap 136 to the body member 130. As shown, the forward attachmentfeature may simply be a slot through which the first end 160 of thewaist strap 136 passes. The body member 130 may also have a rearwardattachment feature (not shown) that attaches to the second end 162 ofthe waist strap 136, either detachably or permanently as set forthabove.

Additionally, the body member 130 may have a shoulder strap fastener 176that is attachable to the rearward end 152 of the shoulder strap 138.The shoulder strap fastener 176 may include a buckle, receiver, or otherfastening element that is easily coupled to the rearward fastener 158 ofthe shoulder strap 138. The shoulder strap fastener 176 may bepositioned on or near the rearward end 168 of the body member 130 asshown.

Yet further, the body member 130 may have a spacer fastener 178positioned on the central portion 172 of the body member 130. The spacerfastener 178 may be designed to removably attach the spacer 132 to thebody member 130. In the embodiment shown in FIG. 2B, the spacer fastener178 may include a component of a hook and loop fastening system (such asan array of loops) that mates with a corresponding component on thesurface of the spacer 132 that faces the body member 130. The spacerfastener 178 may cover a relatively wide area on the body member 130 soas to provide secure attachment of the spacer 132 to the body member130.

The body member 130 may be formed of one or more sturdy, rigid,lightweight materials. The body member 130 may beneficially be formed ofwater-resistant materials so that the brace 100 can be used in a shower,bath, swimming pool, or other aqueous environment. The spacer 132, thearm member 134, the waist strap 136, and the shoulder strap 138 maysimilarly be formed of water-resistant materials.

If desired, the body member 130 may be curved or otherwise contoured tolie against the torso 126 of the user 110. More precisely, aninward-facing surface 180 (the surface of the body member 130 that facesthe torso 126, which faces away from the viewpoint of FIG. 2B) may becurved about a vertical axis such that the forward end 166 and therearward end 168 of the body member 130 both curve toward the waiststrap 136. Additionally, or alternatively, the body member 130 may becurved about a horizontal axis such that the top end 170 is angledinward or outward, toward or away from the torso 126. The body member130 may have an outward-facing surface 182 with similar contouring, orthe outward-facing surface 182 may be substantially planar so as topromote secure attachment of the spacer fastener 178 with the spacer132. If the inward-facing surface 180 is curved, the outward-facingsurface 182 may be made planar by varying the thickness of the bodymember 130, for example, by making the body member 130 thicker at theforward end 166 and/or the rearward end 168, where the inward-facingsurface 180 is curved toward the waist strap 136.

Contouring of the body member 130 may optionally be customized to thepatient. For example, the brace 100 may be one of a kit includingseveral body members 130 that differ from each other in size, curvature,and/or other characteristics. The body member 130 to be used for theuser 110 may be selected from the kit based on the size, shape, gender,surgery type, and/or other characteristics of the user 110.

Additionally or alternatively, contouring of the body member 130 may becustomized by molding, bending, or otherwise shaping the body member 130to fit the body of the brace 100. For example, the body member 130 mayinclude a thin metal core (not shown), which may be sheathed in afabric, mesh, polymer, or other softer cover. The metal core may bebendable, by hand, or through the use of a mechanical bender, to fit thebrace 100. A core made of a plastics, ceramic, composite, or othermaterial may additionally or alternatively be used. A shape memory alloyor other thermally active material may be used to enable the applicationof thermal energy to the metal core to facilitate shaping of the bodymember 130 and/or cause the body member 130 to retain the shape applied.

Furthermore, the inward-facing surface 180 of the body member 130 mayhave a corrugated, mesh-like, or otherwise irregular surface. Suchsurface irregularity may help avoid sweating or chafing of the user 110by facilitating air exchange with the surface of the torso 126 incontact with the body member 130.

Referring to FIG. 3 , a perspective view illustrates the spacer 132 ofthe brace 100 of FIGS. 1A and 1B in greater detail. As shown, the spacer132 may have an inward-facing surface 184 that attaches to theoutward-facing surface 182 of the body member 130, and an outward-facingsurface 186 that attaches to the inward facing surface of the arm member134. Further, the spacer 132 may have a forward end 188, a rearward end190, and a top end 192, which may, after attachment of the spacer 132 tothe body member 130, lie alongside the forward end 166, the rearward end168, and the top end 170 of the body member 130, respectively. Thespacer 132 may thus have a T-shape that generally conforms to the shapeof the body member 130.

The spacer 132 may have a body member fastener 194 that is designed tobe removably attached to the spacer fastener 178 of the body member 130.The body member fastener 194 may thus be of a type complementary to thatof the spacer fastener 178. For example, if the spacer fastener 178 isthe loop component of a hook and loop fastening system, the body memberfastener 194 may be the hook component that interfaces with and attachesto it. The body member fastener 194 may cover a large portion of thesurface 184 so as to provide secure attachment of the spacer 132 to thebody member 130.

The spacer 132 may have a wedge shape as shown in FIG. 3 . Moreprecisely, the spacer 132 may be angled such that the bottom is thickerthan the top, thus positioning the surface 186 and the surface 184 at anonzero angle relative to each other. As shown, this angle may be 15°.However, in alternative embodiments, a larger or smaller angle may beused. For example, the angle may range from 0° to 30°. Further, theangle may range from 5° to 25°. Yet further, the angle may range from10° to 20°. The angle between the inward-facing surface 184 and theoutward-facing surface 186 may not be uniform if either of theinward-facing surface 184 and the outward-facing surface 186 isnon-planar.

The inward-facing surface 184 may have a shape that matches that of theoutward-facing surface 182 of the body member 130. Thus, if theoutward-facing surface 182 of the body member 130 is planar, theinward-facing surface 184 may also be planar. Similarly, if theoutward-facing surface 182 of the body member 130 is contoured, theinward-facing surface 184 may have a matching contour. Theoutward-facing surface 186 may similarly have a shape that matches thatof the arm member 134, and may thus be planar or contoured as well. Theinward-facing surface 184 and the outward-facing surface 186 may havethe same or different planarity or contouring. Thus, the spacer 132 mayhave a uniform thickness or a variable thickness from the forward end188 to the rearward end 190. The spacer 132 may be formed of arelatively rigid, lightweight substance such as rigid foam.

The wedge shape of the spacer 132 may help to angle the arm 112 of theuser 110 so that the elbow 118 is positioned some distance from thetorso 126. This displacement may help to position the shoulder 114 ofthe user 110 in a position that more properly facilitates recovery ofthe shoulder 114, depending on the procedure from which recovery isneeded. If desired, the brace 100 may be positioned to enable the arm112 to be positioned at a variety of angles and displacements relativeto the body member 130. For example, a kit according to the disclosuremay include a plurality of spacers 132 of different shapes and sizes. Insuch a kit, the spacers 132 may have a variety of angles between theinward-facing surface 184 and the outward-facing surface 186 so that thearm 112 of the user 110 can be positioned at the appropriate position.

Additionally, or alternatively, a spacer 132 may be custom-shaped tosuit the user 110. The spacer 132 may be cut to the appropriate sizeprior to attachment to the body member 130 and/or the spacer 132.Alternatively, the spacer 132 may be formed of a shape memory substancesuch as rigid memory foam. The spacer 132 may be compressed, molded, orotherwise formed into the desired shape, and then the appropriateactivation mechanism (such as temperature) may be used to keep thespacer 132 in that shape.

In alternative embodiments, a spacer (not shown) may have an adjustableshape. For example, such a spacer may be shaped like the spacer 132 ofFIG. 3 , but with an inward-facing surface and an outward-facing surfacethat are on separate members that are translatably and/or pivotablycoupled together with a hinge, worm gear, lockable sliding interface, orthe like to enable the angle and/or spacing between the inward-facingsurface and an outward-facing surface to be adjusted. Such a design mayobviate the need for a kit with multiple spacers.

Referring to FIG. 4 , a perspective view illustrates the spacer 132 ofthe brace 100 of FIGS. 1A and 1B from a viewpoint generally opposite tothat of FIG. 3 . FIG. 4 more clearly illustrates one possible shape ofthe spacer 132 in which the surface 184 may be contoured while thesurface 186 is substantially planar.

As shown, an arm member fastener 196 may be attached to theoutward-facing surface 186 to attach the arm member 134 to the spacer132. Like the spacer fastener 178 and the body member fastener 194, thearm member fastener 196 may be any type of fastening device. As shown inFIG. 4 , the arm member fastener 196 may be a component of a hook andloop fastening system, and may more specifically be the hook component.

Referring to FIG. 5A, a rear elevation view illustrates the arm member134 in greater detail. As shown, the arm member 134 may have aninward-facing surface 141 and an outward-facing surface 143. The armmember 134 may further have a forward end 144, a rearward end 145, and atop end 146, which may generally align with the forward end 166, thecentral portion (forward of the rearward end 168), and/or the top end170, respectively, of the spacer 132.

The arm member 134 may have an L-shape that generally parallels that ofthe arm 112 of the user 110. The arm member 134 may be formed of arelatively stiff, durable material such as high-density foam. A fabriccovering or the like may optionally be used. The arm member 134 may besubstantially flat as shown. Alternatively, the arm member 134 may havecontouring to enable it to more closely match the shape of the arm 112.

The arm member 134 may have a shoulder strap fastener 147, which may besimilar to the shoulder strap fastener 176 of the body member 130. Theshoulder strap fastener 147 may thus include a buckle, receiver, orother fastening element that is easily coupled to the forward fastener156 of the shoulder strap 138. The shoulder strap fastener 147 may bepositioned on or near the forward end 144 of the arm member 134 asshown.

The arm member 134 may also have a spacer fastener 148 that facilitatesattachment of the arm member 134 to the spacer 132. The spacer fastener148 may be designed to be removably attached to the arm member fastener196 of the spacer 132. The spacer fastener 148 may thus be of a typecomplementary to that of the arm member fastener 196. For example, ifthe arm member fastener 196 is the hook component of a hook and loopfastening system, the spacer fastener 148 may be the loop component thatinterfaces with and attaches to it. The spacer fastener 148 may cover alarge portion of the inward-facing surface 141 so as to provide secureattachment of the arm member 134 to the spacer 132.

The arm member 134 may also be part of a kit with multiple arm members134 of different shapes and/or sizes to enable the brace 100 to be usedfor patients of different sizes, shapes, and genders. Thus, an armmember 134 of the proper size and/or shape may simply be selected fromthose within the kit.

Alternatively, the arm member 134 may be modifiable to customize it fora given patient. For example, like the body member 130, the arm member134 may optionally include a thin metal plate, shape memory material, orother structure malleable enough to permit the arm member 134 to beshaped to fit the arm 112 of the user 110.

Additionally, or alternatively, the arm member 134 may be large enoughfor larger patients, and may be cut down to size for smaller patients.For example, the arm member 134 may have break lines 149 positionedproximate the forward end 144 and the top end 146. The break lines maybe locations at which the arm member 134 may be relatively easily brokento shorten the forward end 144 and/or the top end 146. The arm member134 may thus have a thin section, pre-stressed region, crack, or otherfeature at the break lines that makes the break lines 149 relativelynatural locations that promote clean, distinct breaks for shortening ofthe forward end 144 and/or the top end 146.

Referring to FIG. 5B, a front elevation view illustrates the arm member134 of the brace 100 of FIGS. 1A and 1B from a viewpoint nearly oppositeto that of FIG. 5A. As shown, the upper arm band 140 and the wrist band142 may have fabric or polymer bands or other elements that wrap aroundthe upper arm 116 and the wrist 122, respectively, of the user 110. Theupper arm band 140 and the wrist band 142 may each include a fastenersuch as a buckle, clasp, hook and loop fastening system, or the likethat permits relatively rapid and easy attachment to and detachment fromthe arm 112 of the user 110.

The arm member 134 may also have a grip 197 proximate the forward end144. The grip 197 may have a rounded shape that provides a resting placefor the hand of the user 110. The arm member 134 may have two gripfasteners 195, either of which may receive the grip 197 to secure thegrip 197 to the outward-facing surface 143. Each of the grip fasteners195 may constitute any known fastener type. If desired, each of the gripfasteners 195 may be a component of a hook and loop fastening system orthe like, such as the loop component illustrated in FIG. 5B.

Each of the grips 197 may have a grip portion 198 and an arm memberfastener 199 positioned on an opposite side of the grip 197 from thegrip portion 198. The grip portion 198 may have an ergonomic shapesuitable for the user to rest his or her hand on the grip portion 198.Accordingly, the grip portion 198 may have a semispherical shape, anovoid shape, or the like. The grip portion 198 may be rigid, or may havea soft and/or textured surface. If desired, the grip portion 198 mayhave a flexible shell filled with a gel or other substance designed tobe comfortable to the hand of the user 110.

In alternative embodiments, a grip portion (now shown) may have aninterface that receives users input so that a user can performactivities while wearing the recovery brace. For example, such a gripportion may include an integrated computer mouse, computer keyboard,vehicular driving controls, remote control, smartphone holder, and/or avariety of other items that can receive user input without requiring theuser to detach any part of the brace 100 from his or her arm.

The arm member fastener 199 may be of a type complementary to the gripfasteners 195. Thus, if the grip fasteners 195 are the loop componentsof hook and loop fastening systems, the arm member fastener 199 may bethe hook portion of such a hook and loop fastening system. The armmember fastener 199 may thus be attached to either of the grip fasteners195 to attach the grip 197 to the desired location on the outward-facingsurface 143.

As shown, the grip fasteners 195 may be positioned on either side of thebreak line 149 that is positioned at the forward end 144. Thus, for apatient with a longer arm, the grip 197 may be secured to the gripfastener 195 that lies forward of the break line 149. For a patient witha shorter arm, the forward end 144 may be severed at the break line 149and the grip 197 may be secured to the remaining grip fastener 195,e.g., the grip fastener 195 that lies rearward of the break line 149.

Referring to FIG. 6 , a perspective view illustrates a shoulder brace200 according to an embodiment of the disclosure. As shown, the brace200 may have a body member 230, a spacer 232, an arm member 234, a waiststrap 236, and a shoulder strap (not shown) that may be similar to theircounterparts of the brace 100. Some of the features of the brace 200that differ from those of the brace 100 will be described below.

The body member 230 may generally have a flexible configuration, whichmay allow it to fit instantly to the shape of the torso 126 of the user.The body member 230 may have an inward-facing surface 280 that has acorrugated shape. The corrugated shape of the inward-facing surface 280may serve a number of functions. For example, the corrugated shape mayfacilitate bending of the inward-facing surface 280 to match the shapeof the torso 126 of the user 110. Further, the corrugated shape maypermit airflow adjacent to the skin and/or clothing covering the torso126 to help prevent excessive sweat, chafing, skin irritation, and otherproblems that may occur with insufficient airflow to a person's skin.The corrugation illustrated is merely exemplary; in other embodiments,an inward-facing surface may have corrugations that are smaller, larger,differently oriented, and/or differently shaped. Alternatively, aninward-facing surface may have a mesh shape or other shape that providesfor airflow against the torso 126 and/or clothing, without having apattern of ridges and/or grooves.

The waist strap 236 may also be different from the waist strap 136. Forexample, rather than attaching to forward and rearward ends of the bodymember 230, the waist strap 236 may encircle the body member 230 and thetorso 126, with ends that fasten together at a fastener 264. Thefastener 264 may be a buckle, clip, or other feature that secures theends of the waist strap 236 together. If desired, the body member 230may have loops or other features that engage the waist strap 236 toensure that the waist strap 236 remains properly positioned on the bodymember 230 as the brace 200 is used.

The spacer 232 may also be different from the spacer 132. For example,the spacer 232 may have a triangular shape or wedge shape that isdesigned to permit the spacer 232 to be used to secure the arm member234 to the body member 230 in multiple relative orientations. The spacer232 may, for example, have the shape of a right triangle as shown inFIG. 6 . The spacer 232 may thus have a first side 284, a second side286, and a third side 288.

The angle between the first side 284 and the second side 286 may be 90°,give or take 5°, 10°, 15°, 20°, or 25°. The angle between the secondside 286 and the third side 288 may be 30°, give or take 5°, 10°, 15°,20°, or 25°. The angle between the first side 284 and the third side 288may be 60°, give or take 5°, 10°, 15°, 20°, or 25°. The angles betweenthe first side 284, the second side 286, and the third side 288 maycause the length of the second side 286 to be less than that of thethird side 288, but more than that of the first side 284.

The body member 230 and the arm member 234 may be attached to anycombination of the first side 284, the second side 286, and the thirdside 288. The sides of the spacer 232 to which the body member 230 andthe arm member 234 are attached may be selected based on the angle atwhich the arm 112 is to extend relative to the torso 126. For example,where the wrist 122 of the arm 112 is to be held relatively close to thetorso 126, the body member 230 and the arm member 234 may be attached tothe second side 286 and the third side 288, as shown, so that the anglebetween the body member 230 and the arm member 234 is relatively small.

By changing how the body member 230 and arm member 234 are attached(e.g., by changing the location that arm member 234 is attached tospaces 232, the brace 200 may be configured, as in FIG. 6 , to keep thewrist 122 relatively close to the torso 126. However, it is appreciatedthat the arm 112 may be supported by the brace 200 in other positionsrelatively close to the torso 126 of the user 110. For example, the bodymember 230 may be attached to the second side 286 of the spacer 232 andthe arm member 234 may be attached to the third side 288 of the spacer232.

In other embodiments, brace 200 can extend the wrist 122 of the arm 112relatively further from the torso 126. For example, attaching to thethird side 288 of the spacer 232, and the arm member 234 may be attachedto the first side 284 of the spacer 232. This may cause the anglebetween the body member 230 and the arm member 234 to correspond to theangle between the third side 288 and the first side 284 (for example,60°), rather than the smaller angle between the second side 286 and thethird side 288 (for example, 30°).

Additionally, the spacer 232 may be attachable to the body member 230and/or the arm member 234 at multiple locations. These locations mayfurther permit adjustment of the angle and/or position of the arm 112relative to the torso 126. In particular, the flexibility of the bodymember 230 may provide it with a rounded shape when worn by the user110; the location of the spacer 232 on the body member 230 may helpdetermine the angle at which the arm 112 is disposed relative to thetorso 126. Other configurations may also be obtained through therepositioning and/or reorientation of the various parts of the brace200.

FIG. 7 illustrates a shoulder brace 300 according to an embodiment ofthe disclosure. Shoulder brace 300 includes three primary components: asupport device 310, an abduction positioning device 320 and a cradledevice 330. In some embodiments, support device 310 includes a pluralityof panels, a soft belt portion and fasteners. In some embodiments, theabduction positioning device 320 includes a rotation coupling member, awedge frame, and a rotational insert. In some embodiments, the cradledevice 330 includes an arm shell and a plurality of fasteners.

FIG. 8 illustrates a support device 310 or waist belt having a flatorientation prior to fitting the belt to a patient. Turning moreparticularly to the support device 310 of FIG. 8 , the support device310 includes a plurality of panels (such as front outer and innerattachment panels and a center panel, shown collectively as 314) toprovide support and rigidity to a fastener (not shown) such as aFidlock® fastener or any suitable magnetic fastening or bucklinginterface. The panels 314 themselves may be constructed from apolyethylene or ethylene vinyl acetate (EVA) foam (e.g., low density 70kg/m3) and are approximately 6 in.×6 in.×0.25 in. In some embodiments,the fasteners are attached to the panels 314 by threading them throughholes cut into the panels 314. The panels 314 are, in turn, attached tothe soft belt portion 312 via, e.g., a Velcro hook adhered to thebackside of the panels 314 using pressure sensitive adhesive.

A center panel 314 may be configured to provide support and rigidity tothe soft belt portion 312 and abduction positioning device 320. Thecenter panel 314 may be constructed from a polyethylene or EVA foam(high density 80 kg/m3) and is approximately 12 in.×6 in.×0.25 in. Thecenter panel 314 may have a contoured geometry such that the abductionpositioning device 320 can nest within the center panel 314 and beprevented from rotating relative to the support device 310. The overallheight of the center panel 314 with the contour is approximately 0.70in. The center panel 314 may be attached to the soft belt portion 312via sewing. In some embodiments, a channel or groove 315 is molded inthe center panel 314, and extends the length of the panel 314. See FIG.9 . As shown, the groove 315 may be configured to receive and retain anabduction wedge frame of the abduction positioning device 320.

In some embodiments, the soft belt portion 312 may be constructed from aperforated polyethylene or EVA core with moisture wicking spacer fabriclaminated on the inside and a mesh loop fabric laminated on the outside.The soft belt portion 312 may be approximately 36 in.×6 in.×0.25 in. Insome embodiments, soft belt portion 312 is configured to be cut to sizefor an individual patient or user.

In some embodiments, the center panel 314 is sewn to two instances ofthe soft belt portions 312 on either side of the panel 314. There may bea channel within the center panel 314 along which the stitching willfollow to secure the components together. Coming off either end of thesoft belt portions 312 are the front outer and inner attachment panels314. Both of these panels 314 are adhered to the outer mesh looplaminate of the soft belt portions 312 by hook that is adhered to thepanels 312 with a pressure sensitive adhesive. On the outer attachmentpanel 314 two instances of Fidlock® fasteners are attached through twoholes cut in the panel. On the inner attachment panel 314 two instancesof corresponding Fidlock® fasteners are attached through two holes cutin the panel. When the belt is wrapped around the patient's torso theouter and inner panels can be brought together and are magnetically andmechanically locked.

FIG. 10 illustrates an isometric view of an abduction positioning device320 in accordance with embodiments of the disclosure. Abductionpositioning device 320 includes an abduction wedge 322 or wedge framethat functions as a support member and carries the load of the patient'sarm. Abduction wedge 322 may be constructed of an aluminum alloy base,over which EVA foam is molded along with an outer layer of laminatedlycra or Velcro loop fabric. In such embodiments, the EVA and fabric mayprovide the abduction wedge a soft touch element to relieve pressurepoint and possible pain associated with wearing the orthosis. Theoverall size of the abduction wedge 322 is approximately 3 in. wide×6.85in. tall×10.5 in. wide×0.375 in. thick.

Abduction positioning device 320 also includes a rotational insert 324configured to engage with the abduction wedge 322 and house a rotationalcoupling member 326. In some embodiments, the rotational insert 324 issnapped into the abduction wedge 322 and serves to set the angle of therotational coupling member 326 and in turn the patient's arm. Therotational insert 324 may be constructed from nylon and is approximately1.75 in. outer diameter×0.85 in. tall×0.60 in. inner diameter. Therotational insert 324 may include two features which snap into the wedgeframe to retain the rotational insert 324 and may include two keyedfeatures to prevent rotation of the rotational insert 324 relative tothe wedge frame. In some embodiments, rotational insert 324 alsoincludes teeth which mate with the rotation coupling member 326 to holdthe desired position, in fixed increments (such as 18° increments). Theinner diameter of the rotational insert 324 may allow a locking member(such as a rod or skewer) to pass through so that the assembly may belocked into fixed position.

FIG. 11 illustrates a cross-sectional view of external/internal rotationcoupling member or rotational coupling member 326. The rotationalcoupling member 326 may include six components—two halves of therotational coupling member itself, two buttons, and two springs. Eachcoupling member may be constructed from nylon and is approximately 6.25in. tall×1.75 in. diameter with an engagement member or cylindricalprotrusion at the center which is approximately 2.25 in. diameter×1 in.tall. The rotational coupling member 326 may include teeth at either endwhich correspond to the teeth in the rotational insert 324, withincrements at fixed positions, e.g., every 18°. The engagement member atthe center may include openings for two spring loaded buttons and tworectangular features which matingly engage a coupling feature on thecradle device 330. FIG. 12 shows the two buttons and the two springs.The buttons may be constructed from nylon and are approximately 0.75in.×0.925 in.×0.30 in. The springs may have dimensions of 0.156 in.diameter×1.25 in. overall length. In some embodiments, the two buttonsreside in channels within the rotational coupling member 326 so as toonly allow for a linear inward/outward motion. The two springs may beconstrained to the two buttons via cylindrical pegs which extend intothe inner diameter of the springs, again so as to only allow the twobuttons to move in a linear fashion. The two halves of the rotationalcoupling member 326 are then fastened together, once assembled with thetwo buttons and two springs, via snap features and screws.

In some embodiments, a locking member or locking skewer (not shown)serves to rigidly lock the abduction positioning device 320 together andmaintain the position of the rotational coupling member 326 relative tothe abduction wedge 322. The locking skewer may be constructed fromnylon and is approximately 7.15 in. tall with a major diameter of 2 in.culminating as a knob and a shaft diameter of 0.60 in. In someembodiments, the locking skewer is placed inside diameter of therotational insert 324 and includes teeth and two keyed features whichmatch that of the rotational insert 324. In some embodiments, there isalso a 0.50 in. minor diameter internal female thread feature whichmates with a male thread feature of the locking skewer. At one end ofthe locking skewer is a locking knob configured to allow for the user'sfingers to grip the knob and rotate it into a closed or open position,locking or releasing the skewer.

FIGS. 12A and 12B illustrate different views of the cradle device inaccordance with embodiments of the disclosure. As shown, the cradledevice 332 includes an arm shell 331. Arm shell 331 may be constructedfrom a combination of nylon and polypropylene and is approximately 13in.×6.5 in.×5 in. Arm shell 331 interfaces with the rotational couplingmember 326 via an attachment mechanism 336. In some embodiments,attachment mechanism 336 mates with the engagement member and twobuttons on the rotational coupling member 326 to constrain the arm shell331 to the abduction positioning device 320.

In some embodiments, arm shell 331 includes Velcro to allow fasteners334 to attach and wrap around the arm of the patient. In someembodiments, a liner (not shown) attaches to the arm shell 331 on aninterior surface and provides padding to the arm.

Fasteners 334 may include a biceps cuff 334 a and a forearm cuff 334 b.Biceps cuff 334 a may attach to the arm shell 331 via Velcro and ismeant to wrap around the patient's arm at the user's biceps. The bicepscuff 334 a may be constructed from a combination of moisture wickingspacer fabric, Velcro hook/loop, edge banding material and molded straptabs. The biceps cuff 334 a is approximately 12 in.×4 in. when thepattern is laid flat. The Velcro attachment is meant to allow foradjustability to accommodate various size arm anatomy.

The forearm cuff 334 b may attach to the arm shell 331 via Velcro and ismeant to wrap around the patient's arm at the user's forearm. Theforearm cuff 334 b may be constructed from a combination of moisturewicking spacer fabric, Velcro hook/loop, edge banding material andmolded strap tabs. The forearm cuff is approximately 10 in.×4 in. whenthe pattern is laid flat. The Velcro attachment is meant to allow foradjustability to accommodate various size arm anatomy.

In some embodiments, a forearm release or drop may be achieved byremoving the forearm cuff 334 b so that the forearm is free to move orby keeping the forearm strapped into the arm shell 331 and engaging abutton (not shown) which unlocks a hinge at the elbow so that theforearm can flex and extend from 90 degrees (locked position) to 180degrees (arm extended straight).

The liner or soft goods which line the arm shell 331 may be constructedfrom a combination of moisture wicking fabric laminated to breathablefoam. The dimensions of the liner are such that they at least partiallyline the interior of the arm shell 331 when attached. The soft goods canbe attached via plastic rivets or Velcro hook and loop.

In some embodiments, Velcro hook/loop is applied to the outside of thearm shell 331 in the areas where the biceps cuff 334 a and forearm cuff334 b will attach. The soft goods which line the interior of the armshell 331 are applied and held in place with plastic rivets which snapinto corresponding holes in the shell body. The biceps cuff 334 a andforearm cuff 334 b are then attached to the Velcro on the outside of thearm shell 331.

FIG. 14 illustrates an arm shell having two symmetric componentsaccording to some embodiments of the disclosure. For example, arm shell430 may include a biceps cradle or support 432 a and a forearm cradle orsupport 432 b. The length of the supports 432 may be extendable bysliding the end 439 of a support outward along a support bar 438. Thisessentially moves the end 439 of support 432 away from attachmentmechanism or joint 436. As shown, there are two attachment mechanisms436 for attachment with abduction positioning device 320.

FIG. 15 illustrates a three-dimensional view of an arm shell accordingto an embodiment of the disclosure and FIG. 16 illustrates athree-dimensional view of a wedge assembly attached to a waist beltaccording to an embodiment of the disclosure. Collectively, FIGS. 15 and16 represent a complete assembly of a shoulder orthosis. To assemble theorthosis, the support device 310 is first pulled through an opening ofthe abduction positioning device 320 until the center panel lines upwith the abduction wedge. The abduction wedge then nests into thecontour of the support device 310 center panel. Finally, the cradledevice 330 is pressed onto the engagement member of the rotationalcoupling member of the abduction wedge via an attachment feature 339 ofthe cradle device 330. This causes the buttons on the rotation couplingmember to depress via ramps molded into the attachment feature 339 ofthe cradle device 330 and then snap back out and into the body of theattachment feature 339 of the cradle device 330. The cradle device 330is then securely affixed to the abduction positioning device 320.

When fitting the orthosis to a patient, a first step is to size thebelt, as it is a universal fit. Remove the front outer and innerattachment panels from the belt and set aside; they are held to the softgoods via Velcro hook and loop. Align the center panel of the belt abovethe patient's iliac crest on the affected side of the body. Wrap thesoft good portion of the belt facing forward around the patient's waistand trim to length; using scissors cut through the soft goods so thatthe front outer attachment panel will ultimately land at the patient'scenterline. Wrap the soft good portion of the belt facing backwardsaround the patient's waist and trim to length; using scissors cutthrough the soft goods so that the front inner attachment panel willultimately land at the patient's centerline. Reattach the front outerattachment panel to the short side of the soft goods of the waist beltwhich faces forwards. Reattach the front inner attachment panel to thelong side of the soft goods of the waist belt which faces backwards andwraps behind the patient's waist. The waist belt should now be snugglyfit to the patient's waist; check to make sure the waist belt is notloose, re-cutting the soft goods if necessary. Now remove the waist beltfrom the patient for use after the next step.

Next select either the 45° or neutral abduction wedge frame dependingupon the desired protocol. Now set the degree of external or internalrotation by aligning indication marks on the rotation coupling member tothe corresponding degree marks on the wedge frame and seat the rotationcoupling member over the rotational insert in the frame. The teeth ofthe rotation coupling member should now be engaged with the teeth of therotational insert thus setting the amount of internal or externalrotation desired. Slide the locking skewer through the keyed hole in thewedge frame and the hole in the rotation coupling member so that itprotrudes from the bottom of the rotational insert of the wedge frame.Take care to align the keyed features of the locking skewer with thosekeyed features of the wedge frame. Now thread locking knob onto thelocking skewer shaft protruding from the bottom of the wedge frame andturn clockwise until seated tightly. The external/internal rotationposition of the abduction wedge is no set, along with the amount ofabduction set by the frame selection (either 45° or neutral).

The abduction wedge can now be secured to the patient's body by slidingthe short end of the waist belt through the center opening in the bodyof the abduction wedge. Center the abduction wedge in the contouredportion of the waist belt center panel such that the inner face of theabduction wedge opposite the rotation coupling member is coincident withthe inside face of the center panel. With the abduction wedge now nestedin the contour of the waist belt center panel place the assembly abovethe patient's iliac crest on the affected side of the body and wrap thelong end of the waist belt soft goods behind the patient, bringing itaround to the front. Now bringing the short end of the waist belt softgoods around the front of the patient, the front inner and outerattachment panels can now be connected via the Fidlock® snap fastenersor any suitable magnetic fastening or buckling interface. This willsecurely hold the abduction wedge in position relative to the patient'sbody.

Finally attach the arm shell to the arm on the affected side of thepatient by seating the arm in the soft goods of the shell. Now, with thebiceps cuff attached to the posterior side of the shell via Velcro hookand loop, bring the biceps cuff around the biceps and secure to theVelcro hook and loop on the anterior side of the shell. Repeat a similarprocess for the forearm cuff, with the forearm cuff attached to thedistal side of the shell via Velcro hook and loop, bring the forearmcuff around the forearm and secure to the Velcro hook and loop on thesuperior side of the shell. Bring the arm shell to the abduction wedgeand snap the coupling feature of the arm shell to the rotation couplingmember. As the arm shell is slid over the mating feature of the rotationcoupling member the spring-loaded buttons on the rotation couplingmember will engage with ramps on the coupling feature of the arm shelland depress. When the coupling feature of the arm shell is fully seatedon the mating feature of the rotation coupling member the buttons returnto their free height in corresponding holes in the arm shell thuslocking the assembly together. The orthosis is now fit to the patient.

The shoulder orthosis described herein can be constructed from a numberof alternative materials and has numerous uses and ranges. For example,for the waist belt attachment and center panels, the panels areconstructed from low density (70 kg/m³) and high density (80 kg/m³)polyethylene foam sheet which is molded to shape. Alternatively, thepanels can be injection molded from polypropylene and function in thesame manner.

The soft goods can be constructed from polyethylene or EVA foam coremolded to shape with loop mesh laminated to the outer surface andmoisture wicking spacer fabric laminated to the inner surface.Alternatively, the soft goods of the waist belt can comprise moisturewicking spacer fabric trimmed in an edge banding material. Overall, thewaist belt could vary in length from 18 in. to 65 in. to cover a rangeof body types and waist sizes.

For the abduction wedge, the wedge frame can be constructed from analuminum substrate and over molded with EVA foam and laminated with astretch fabric or UBL nylon. The wedge frame could also be over moldedwith different density foams, fabrics or textiles on either one or bothsides. Alternatively, the frame could be an injection molded partconstructed from nylon, ABS or other suitably strong plastic resin. Thecurrent embodiment of the wedge frame comes in two configurations, 45°and neutral, but could also be adjustable within a range from neutral to90° of abduction. Additionally, the wedge frame could be in a range ofdifferent thicknesses, widths or shapes based on strength requirementsand geometry.

The rotation coupling member can be injection molded from nylon, but itcould also be molded from ABS or other suitably strong plastic resin.Internal to the rotation coupling member are teeth which set the degreeof rotation relative to the wedge frame. Currently these are set at 18°increments but could be within a range of 5° to 90° increments. Thediameter around which the teeth are patterned is currently 1.30 in. butcould range from 0.75 in. upwards depending on the strength requirementsand size envelope of the surrounding components. The coupling matingfeature with the arm shell can also range in size from 1 in. to 3 in. indiameter and 1 in. to 4 in. in length. The overall height of therotation coupling member is 6.25 in. but can vary in a range from 1 in.to 8 in.

The locking skewer may be injection molded from nylon, but it could alsobe molded from ABS or other suitably strong plastic resin. The size andshape of the locking skewer can vary with that of the rotation couplingmember, as they are mating components.

The locking knob may be injection molded from nylon, but it could alsobe molded from ABS or other suitably strong plastic resin. The size andshape of the locking knob can vary with that of the locking skewer, asthey are mating components. The thread size and form can vary betweenthe knob and skewer depending on the overall size and geometry of thecomponents and the strength requirements. Additionally, the connectioncan be something other than a threaded connection, such as: a snapfeature with a release mechanism, a magnetic connection, a quarter turnfastener, or Christmas tree shaped barb. The finger grip to turn theknob can also vary in height, width and shape to give the best ergonomicshape which conforms with the anatomy of the user.

The rotational insert may be injection molded from nylon, but it couldalso be molded from ABS or other suitably strong plastic resin. The sizeand shape of the rotational insert can vary with that of the rotationcoupling member, locking knob and locking skewer, as they are matingcomponents.

The arm shell may be injection molded from a combination of nylon andpolypropylene, but it could also be molded from ABS or other suitablystrong plastic resin. The overall size and shape can vary to capture arange of arm size and anatomical shapes. A movable extension to supportthe hand and wrist may be included, such as shown in FIG. 14 . The shellcan also be a single or multiple component assembly utilizing a nylon orABS backbone with a flexible polypropylene shell.

The biceps and forearm cuffs may be constructed from a moisture wickingspacer fabric with edge banding and Velcro hook and loop attachment tothe shell. Alternatively the cuffs could be constructed from a moldablealuminum over molded or covered with formed foam and laminated fabric.The attachment to the arm shell can alternatively be a trimmable fabricor dual sided hook and loop material which is secured to the shellthrough a slot on one side and threaded through a slot on the otherside, then folded back onto itself for closure. Additionally, the cuffscould use molded buckles which snap onto or attach to the shell andutilize straps which would be adjustable. The size and shape of thecuffs can also vary to fit patient anatomy and arm size.

The soft goods which line the interior of the shell (e.g., form theliner) may be constructed from an open or closed cell foam laminatedwith a moisture wicking spacer fabric. The soft goods could utilizealternative foams and laminates, such as memory shape foams and fabricswhich regulate temperature as well as moisture.

FIG. 17 illustrates a shoulder brace 500 according to an embodiment ofthe disclosure. Shoulder brace 500 is configured to immobilize the arm,and in turn the shoulder joint, in neutral abduction/adduction to 45°,external rotation of 0-50° and internal rotation of 0-60°. Shoulderbrace 500 includes three primary components: a support device 510, anabduction positioning device 520 and a cradle device 540, which allowfor a low-profile design while minimizing the need for additional strapswhich go around the neck. The abduction positioning device 520 mayinclude an external/internal rotation coupling member or rotationalcoupling member 530. In some embodiments, cradle device 540 provides adrop out means to allow for flexion/extension of the forearm whichfacilitates daily living activities.

FIG. 18 illustrates a support device or arch 520 configured to conformto the user's torso in communication with external/internal rotationcoupling member 540. In some embodiments, the arch 520 provides themeans by which abduction of the users arm is adjusted. For example, arch520 may be a flexible member constructed from polypropylene that canconform to different size users or patients and adjust abduction bychanging curvature. This change in curvature of the arch 520 may beaccomplished by lengthening or shortening a strap (not shown) that runsalong the base of the arch 520. This strap length change moves the apexof arch 520 (where cradle device 540 attaches) further out or closerinto the torso, thereby increasing or decreasing the abduction of theusers arm. In some embodiments, arch 520 is approximately 6 in. tall×24in. long (arc length)×19 in. across base×0.25 in. thick.

FIG. 19 illustrates a cross-sectional view of external/internal rotationcoupling member 530. In some embodiments, external/internal rotationcoupling member 530 sets the rotation of the arm relative to the body bymeans of teeth 532 within an outer rotation coupling, an inner rotationcoupling and a rotation button 538. FIG. 5 shows the cross section ofthe assembly. In some embodiments, the outer rotation coupling mateswith the inner rotation coupling and is where the cradle device 540attaches. External rotation coupling is generally cylindrical in shapewith a minor diameter approximately of 1.75 in×1.5 in. long. Protrudingfrom the cylindrical body is another cylindrical body perpendicular toit with teeth patterned around the interior. These parts may beconstructed from either a nylon or ABS polymer.

In some embodiments, the inner rotation coupling mates with the outerrotation coupling. Inner rotation coupling is generally spherical inshape with flat ends and a diameter of approximately 2.5 in. It hasmatching teeth which overlap the outer rotation coupling when viewedfrom the top. There is an approximately 0.25 in. wide slot in the backof the body to allow the coupling to pivot in the sagittal plan of thebody (e.g., when user is wearing device 500). These parts may beconstructed from either a nylon or ABS polymer.

In some embodiments, rotation button 538 has teeth that are patternedaround its circumference which when mated within the teeth 532 of theouter and inner couplings, lock the two couplings relative to eachother. The button diameter is approximately 1.23 in. and isapproximately 1.125 in. in length. There are two grooves cutting throughthe teeth circumferentially which are approximately 0.150 in. wide,allowing the teeth of the outer rotation coupling to pass through. Thispart may be constructed from either a nylon or ABS polymer.

Arm buttons 534 may be constructed from nylon and are approximately 0.75in. diameter×0.625 in. tall. A spring may be nested inside the diameterof the buttons 534 so that they can retract and return when the cradledevice 540 is attached. The two buttons 534 reside in channels withinthe outer rotation coupling member so as to only allow for a linearinward/outward motion. This part may be constructed from either a nylonor ABS polymer. Two springs (not shown) reside under the rotation button538 and within the inner rotation coupling. The springs areapproximately 0.70 in. diameter×0.5 in. tall and made from spring steel.

FIG. 20 illustrates an inner strap configuration of support device 510and FIG. 21 illustrates an outer strap configuration of a support device510. The inner strap configuration includes inner strap 512, which has agenerally straight linear geometry and is approximately 4 in. wide,which then necks down to 2 in. wide to pass through slots 513 a and 513b in arch 520. In some embodiments, inner strap 512 is configured toform a partial barrier 515 between the torso of the user and abductionpositioning device 520.

The outer strap configuration includes an outer strap 516. The outerstrap 516 may be a “Y”-shaped belt having a first portion with one endand a second portion with two ends 516 a and 516 b. The Y-shaped beltmay be approximately 4 in. wide on two ends 516 a, 516 b and then necksdown to 2 in. wide to pass through slots 517 a in arch 520. In someembodiments, two ends 516 a, 516 b of the outer strap 516 then connectto a semi-rigid panel 518 which houses a fastener, such as a Fidlock®fastener or any suitable magnetic fastening or buckling interface.

FIG. 22 illustrates a plurality of y-shaped outer strap designs A, B,and C and FIG. 23 illustrates an assembled support device 510. In someembodiments, inner straps 512 and outer strap 516 are constructed frommoisture wicking spacer fabric on one side and unbroken loop (UBL) nylonfabric on another side.

FIG. 24 illustrates an assembled shoulder brace 500 according to anembodiment of the disclosure. While not specifically depicted in aseparate figure because a similar cradle device is described in FIG. 12, cradle device 540 includes an arm shell configured to interface withthe rotation coupling member 530. The arm shell may be constructed froma combination of nylon and polypropylene and is approximately 13 in.×6.5in.×5 in. The arm shell may include an attachment feature which mateswith an engagement member and two buttons on the rotation couplingmember 530 to constrain the arm shell to the abduction positioningdevice 520. In some embodiments, there is Velcro on the arm shell toallow a biceps cuff and forearm cuff to attach and wrap around the armof the user. Finally, there may be soft goods which also attach to thearm shell to pad the arm.

In some embodiments, the external/internal rotation member 530 isattached to the arch 520 by a slot on the backside of the inner rotationcoupling (e.g., when the two halves of the coupling are fastened). Theremay be protrusions in the arch 520 which mate to this slot and constrainthe assembly to only pivot in the sagittal plane (when the patient iswearing device 500). The two halves of the outer rotation coupling arethen seated in the inner rotation coupling halves such that the teeth532 of each overlap. The arm buttons 538 and spring are seated withinthe halves of the outer rotation couplings and then the halves arefastened. The two 0.70 in.×0.50 in. springs are placed in either side ofthe inner rotation coupling and the rotation buttons 538 are theninserted into the inner coupling. The two rotation buttons 538 have amating feature which orients and fixates one side of the button to theother such that the teeth of each align. A screw is then used to fastenthe two buttons together. Now when the rotation button 538 is depressedfrom either side the circumferential groove in the button teeth willallow the teeth of the outer rotation coupling to pass so as to adjustthe amount of external or internal rotation. A Fidlock® fastener or anysuitable magnetic fastening or buckling interface may be attached to acircular boss on the arch 520 to allow for attachment of the straps 510.

In some embodiments, there are two straps 512, 516 for the archassembly. The inner strap 512 attaches to a slot 513 b to the left ofthe external/internal rotation member 530 and then passes through a slot513 a on the right side opposite where it attaches. The strap 512 isthen brought back around to the slot 513 b on the left side and attachedvia hook and loop. This strap 512 adjusts the amount of curvature of thearch 520 by lengthening or shortening the strap 512 and in effect theamount of abduction of the users arm. The outer strap 516 attaches to aslot 517 a on the right of the external/internal rotation member 530 andthen passes through an opposite slot opening on the left side (notshown). The outer strap 516 is in the shape of a “Y” such that the twoends 516 a, 516 b of the strap 516 connect to a semi-rigid panel 518which houses a Fidlock® fastener or any suitable magnetic fastening orbuckling interface. This “Y” shape may allow the orthosis to fit amultitude of body types and prevent the orthosis from sliding down theusers torso. The panel 518 can then attach to a corresponding fasteneron arch 520. This facilitates one handed application of the orthosis.

In some embodiments, a Velcro hook/loop is applied to the outside of thearm shell in the areas where the biceps and forearm cuff will attach.The soft goods which line the interior of the shell are applied and heldin place with plastic rivets which snap into corresponding holes in theshell body. The biceps and forearm cuffs are then attached to the Velcroon the outside of the shell.

When fitting the orthosis to a patient, a first step is to size theinner strap to obtain the correct amount of abduction required for thepatient. The strap end is pulled tight and cut to length. An alligatortab is then attached to the end of the strap via hook and loop andsecured in place. This has now tensioned the arch and adjusted thecurvature to provide a set amount of abduction when the orthosis isplaced against the user or patient's body. Next the outer strap isadjusted such that the 4 in. wide portion of the strap is in the outermost slot towards the posterior of the patient. The fastening panel isthen brought around the back of the patient, towards the front endattached to the Fidlock® fastener on the front of the arch. The twolengths of the “Y” of the outer strap are then adjusted so that theorthosis is snug on the patient's body. The excess of these straps canbe cut and discarded. At this point, if the patient needs to put on ortake off the orthosis, they only need to use the Fidlock® fastener orany suitable magnetic fastening or buckling interface.

The arm shell is next attached to the arm on the affected side of thepatient by seating the arm in the soft goods of the shell. Now, with thebiceps cuff attached to the posterior side of the shell via Velcro hookand loop, bring the biceps cuff around the biceps and secure to theVelcro hook and loop on the anterior side of the shell. Repeat a similarprocess for the forearm cuff, with the forearm cuff attached to thedistal side of the shell via Velcro hook and loop, bring the forearmcuff around the forearm and secure to the Velcro hook and loop on thesuperior side of the shell. Bring the arm shell to the external/internalrotation member and snap the coupling feature of the arm shell to theouter rotation coupling. As the arm shell is slid over the matingfeature of the rotation coupling, the spring-loaded buttons on therotation coupling will engage with ramps on the coupling feature of thearm shell and depress. When the coupling feature of the arm shell isfully seated on the mating feature of the rotation coupling, the buttonsreturn to their free height in corresponding holes in the arm shell thuslocking the assembly together. Finally, depress the rotation button toadjust the amount of external or internal rotation of the patient's arm.Release the button to allow the internal springs to equalize the buttonposition and engage the teeth on the inner and outer couplings. The armshould now be locked into place and the orthosis fit to the patient.

In some embodiments, the arch structure may be constructed frompolypropylene, polyethylene or another thermoplastic resin that allowsfor compliance so that the arch and change curvature without fatiguingor cracking. In some embodiments, the external/internal rotation membermay be constructed from a number of thermoplastic resins, includingnylon, nylon with glass fill, or ABS.

In some embodiments, the arm shell is injection molded from acombination of nylon and polypropylene, but it could also be molded fromABS or other suitably strong plastic resin. The overall size and shapecan vary to capture a range of arm size and anatomical shapes. Theaddition of a movable extension to support the hand and wrist is also anoption. The arm shell may be a single or multiple component assemblyutilizing a nylon or ABS backbone with a flexible polypropylene shell.Additionally, the arm shell may be of a configuration such as the X-ActRom Elbow product which utilizes a stamped metal frame (e.g., aluminum)and moldable cuffs.

In some embodiments, the biceps and forearm cuffs are constructed from amoisture wicking spacer fabric with edge banding and Velcro hook andloop attachment to the arm shell. Alternatively, the cuffs may beconstructed from a moldable aluminum over molded or covered with formedfoam and laminated fabric. The attachment to the arm shell canalternatively be a trimmable fabric or dual sided hook and loop materialwhich is secured to the shell through a slot on one side and threadedthrough a slot on the other side, then folded back onto itself forclosure. Additionally, the cuffs could use molded buckles which snaponto or attach to the shell and utilize straps which would beadjustable. The size and shape of the cuffs can also vary to fit patientanatomy and arm size.

In some embodiments, the soft goods which line the interior of the armshell (e.g., the liner) are constructed from open or closed cell foamlaminated with moisture wicking spacer fabric. The soft goods mayutilize alternative foams and laminates, such as memory shape foams andfabrics which regulate temperature as well as moisture.

The disclosed shoulder orthosis has significant advantages over previousshoulder braces. Some of the advantages include its lightweightconstruction, ease of application with minimum steps, quick connectfasteners, as well as easy and quick abduction and external/internalrotation. Additionally, the brace provides a precise amount of abductionand external/internal rotation. Advantageously, the brace is breathableand includes a drop out design.

By separating the orthosis into three components the operating roomstaff is able to slide the waist belt under the patient without theextra bulk of the abduction mechanism and arm shell, unlike otherproducts that combine all the components into one piece. Since thepatient is unconscious, or sedated, having a separate waist beltcomponent which is low-profile makes it easier to position the productbetween the patient and the operating table. There are a minimum numberof steps involved in applying the orthosis making it quick and easy forthe operating room staff to apply. By using quick connect fasteners onthe waist belt and a quick connect coupling between the abduction wedgeand arm shell, applying the orthosis is quick and easy.

Using moisture wicking spacer fabric laminated to perforated foam theorthosis is breathable and manages heat at the point of application. Theperforated foam and low-profile design on the waist belt also improvethe comfort of the orthosis, minimizing the amount of material aroundthe patient's back. This has the added benefit of reducing thediscomfort when the wearer of the orthosis is in a sitting or sleepingposition by removing unnecessary bulk.

Many of the current products on the market do not allow for quick andeasy adjustment of the abduction or external/internal rotation of theorthosis. By utilizing a locking skewer and knob design,external/internal rotation of the orthosis is quickly set to a preciseamount. The use of inserts which have teeth spaced at desired incrementsit is possible to precisely set the amount of external/internal rotationand maintain that degree of rotation if the orthosis is taken off andput back on.

Additional features include the ability to drop the forearm out of thearm shell so that patients can function in daily life activities whilestill keeping the shoulder immobilized.

Methods of using the disclosed shoulder brace are likewise provided.Uses can include the treatment of glenohumeral dislocation orsubluxation, capsular shifts, posterior shoulder stabilizations, Bankartrepairs, release severe anterior capsule contracture, soft tissuestrains or repairs, rotator cuff repairs, total shoulder replacement,superior labral repairs (SLAP), shoulder debridement, fractures(humerus, elbow, forearm), biceps tendon repair, elbow ligament/tendonrepair, anterior shoulder laxation and AC joint reconstruction.

In some embodiments, the brace may be modified to include aspring-loaded push button to lock and release the rotation couplingmember via internal gear teeth.

Reference throughout this disclosure to “an embodiment” or “theembodiment” means that a particular feature, structure or characteristicdescribed in connection with that embodiment is included in at least oneembodiment. Thus, the quoted phrases, or variations thereof, as recitedthroughout this disclosure are not necessarily all referring to the sameembodiment.

Similarly, it should be appreciated that in the above description ofembodiments, various features are sometimes grouped together in a singleembodiment, Figure, or description thereof for the purpose ofstreamlining the disclosure. This method of disclosure, however, is notto be interpreted as reflecting an intention that any claim in this, orany, application claiming priority to this application, require morefeatures than those expressly recited in that claim. Rather, as thefollowing claims reflect, inventive aspects lie in a combination offewer than all features of any single foregoing disclosed embodiment.Thus, the claims following this Detailed Description are herebyexpressly incorporated into this Detailed Description, with each claimstanding on its own as a separate embodiment. This disclosure includesall permutations of the independent claims with their dependent claims.

Recitation in the claims of the term “first” with respect to a featureor element does not necessarily imply the existence of a second oradditional such feature or element. Elements recited inmeans-plus-function format are intended to be construed in accordancewith 35 U.S.C. § 112 Para. 6. It will be apparent to those having skillin the art that changes may be made to the details of theabove-described embodiments without departing from the underlyingprinciples of the disclosure.

While specific embodiments and applications of the present disclosurehave been illustrated and described, it is to be understood that thedisclosure is not limited to the precise configuration and componentsdisclosed herein. Various modifications, changes, and variations whichwill be apparent to those skilled in the art may be made in thearrangement, operation, and details of the methods and systems of thepresent disclosure disclosed herein without departing from the spiritand scope of the disclosure.

What is claimed is:
 1. A method of manufacturing an orthopedic shoulderdevice, comprising: providing a cradle device configured to receive andsupport a portion of an arm of a user; assembling an abductionpositioning device by coupling the cradle device to an apex of aflexible arch utilizing a rotation coupling member such that adjustingan amount of curvature of the flexible arch adjusts an angle ofabduction of the arm of the user relative to a torso of the user; andproviding at least one strap for coupling between at least two locationson the flexible arch such that the amount of curvature of the flexiblearch is adjusted by adjusting an amount of the at least one strapcoupled between the at least two locations on the flexible arch.
 2. Themethod of claim 1, wherein providing the cradle device comprises:constructing an arm shell configured to provide a resting support forthe arm of the user; and constructing a plurality of fastenersconfigured to surround and hold the arm of the user in place against thearm shell.
 3. The method of claim 1, wherein the arm shell comprises asemi-rigid structure configured to restrict movement of the arm of theuser.
 4. The method of claim 1, further comprising covering a portion ofan interior surface of the cradle with a liner configured to providepadding to the arm of the user.
 5. The method of claim 1, wherein the atleast one strap comprises an inner strap and the at least two locationson the flexible arch comprise: a first slot formed at a first portion ofthe flexible arch that is disposed in a first direction from the apex ofthe flexible arch; and a second slot formed at a second portion of theflexible arch that is disposed in a second direction from the apex ofthe flexible arch opposite the first direction.
 6. The method of claim5, wherein the inner strap is configured to form a partial barrierbetween the torso of the user and the flexible arch, the size of thepartial barrier being adjustable by shortening or lengthening the innerstrap.
 7. The method of claim 1, wherein the at least one strapcomprises an outer strap and the at least two locations on the flexiblearch comprise: a first slot formed at a first portion of the flexiblearch that is disposed in a first direction from the apex of the flexiblearch; and a fastener formed at a second portion of the flexible archthat is disposed in a second direction from the apex of the flexiblearch opposite the first direction.
 8. The method of claim 7, wherein theouter strap is substantially Y-shaped, having a first end, a second endand a third end, and wherein the first end is configured to couple tothe first slot and the second end and the third end is configured tocouple to a semi-rigid panel configured to attach to the fastener. 9.The method of claim 7, wherein the outer strap is configured to bewrapped around the torso of the user.
 10. The method of claim 1, whereinthe flexible arch is constructed such that adjusting the amount ofcurvature of the flexible arch simultaneously adjusts a distance of theapex of the flexible arch from the torso of the user, thereby adjustingthe angle of abduction of the arm of the user.
 11. The method of claim1, wherein at least a portion of the flexible arch is constructed toconform to the torso of the user.
 12. The method of claim 1, wherein therotation coupling member comprises: an outer rotation coupling; an innerrotation coupling; and a rotation button configured to: fix a relativeorientation of the outer rotation coupling with respect to the innerrotation coupling in a first position, and allow relative rotationbetween the outer rotation coupling and the inner rotation coupling in asecond position.
 13. The method of claim 12, wherein the rotationcoupling member is configured to adjust at least one of an angle ofinternal rotation and an angle of external rotation of the arm of theuser relative to the torso of the user by adjusting a relativeorientation of the outer rotation coupling with respect to the innerrotation coupling.
 14. The method of claim 12, further comprisingmatingly engaging the internal rotation coupling with the externalrotation coupling to form the rotation coupling member.
 15. The methodof claim 12, further comprising, when the rotation button is disposed inthe first position, mating a first plurality of teeth of the rotationbutton with a second plurality of teeth of the outer rotation coupling.16. The method of claim 15, wherein the rotation button comprises atleast one groove cutting through the first plurality of teeth such thatthe second plurality of teeth of the outer rotation coupling rotatefreely within the at least one groove when the rotation button is in thesecond position, thereby allowing adjustment of at least one of an angleof internal rotation and an angle of external rotation of the arm of theuser relative to the torso of the user.
 17. The method of claim 12,wherein the rotation coupling member further comprises: an engagementmember configured to couple the rotation coupling member to the cradledevice; and a plurality of engagement buttons configured to releasablyengage the engagement member with the cradle device.
 18. A method ofutilizing an orthopedic shoulder device, comprising: receiving andsupporting a portion of an arm of a user in a cradle device of theorthopedic shoulder device; and adjusting an amount of a strap coupledbetween at least two locations on a flexible arch of an abductionpositioning device of the orthopedic shoulder device to, thereby, adjustan amount of curvature of the flexible arch, the abduction positioningdevice further comprising a rotation coupling member coupling the cradledevice to an apex of the flexible arch such that adjusting the amount ofcurvature of the flexible arch adjusts an angle of abduction of the armof the user relative to a torso of the user.
 19. The method of claim 18,wherein the flexible arch is configured such that adjusting the amountof curvature of the flexible arch simultaneously adjusts a distance ofthe apex of the flexible arch from the torso of the user, therebyadjusting the angle of abduction of the arm of the user.
 20. The methodof claim 18, wherein the rotation coupling member comprises: an outerrotation coupling; an inner rotation coupling; and a rotation buttonconfigured to: fix a relative orientation of the outer rotation couplingwith respect to the inner rotation coupling in a first position, andallow relative rotation between the outer rotation coupling and theinner rotation coupling in a second position.